Package leaflet: information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Tardyferon-Fol (gyno-Tardyferon)
80 mg + 0.35 mg, prolonged-release tablets
Ferrosi sulfas + Acidum folicum
Tardyferon-Fol and gyno-Tardyferon are different trade names for the same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Tardyferon-Fol is and what it is used for
Important information before taking Tardyferon-Fol
How to take Tardyferon-Fol
Possible side effects
How to store Tardyferon-Fol
Contents of the pack and other information

1. What Tardyferon-Fol is and what it is used for

Tardyferon-Fol is a combination medicine containing ferrous sulfate and folic acid. Iron is released slowly and evenly, thereby reducing the risk of local accumulation in the stomach and intestine, which improves the drug's tolerability. The delayed release has a beneficial effect on iron absorption in the intestine. Folic acid is rapidly absorbed.

During pregnancy, the body's demand for iron increases significantly, making iron deficiency common. Initially, iron deficiency may cause general symptoms such as reduced appetite or rapid fatigue, without signs of anaemia. Only when iron deficiency becomes substantial—that is, when there is insufficient iron for the essential production of haemoglobin—does overt iron deficiency with anaemia develop. General symptoms worsen, and additional signs such as fissures at the corners of the mouth, brittle nails, and hair may occur.

Significant folic acid deficiency may lead to disturbances in the production of red blood cells, white blood cells, and platelets; however, this condition is rare.

Tardyferon-Fol is used for the prevention and treatment of iron and folic acid deficiencies in pregnant women.
Tardyferon-Fol is indicated for use in pregnant women.

2. Important information before using Tardyferon-Fol

When not to use Tardyferon-Fol:

if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
in all cases of anemia due to causes other than iron deficiency;
in cases of iron accumulation (hemochromatosis, chronic hemolysis, frequent transfusions);
in cases of impaired iron utilization (sideroachrestic anemia, lead poisoning-induced anemia, thalassemia, late cutaneous porphyria);
in cases of confirmed iron intolerance (e.g. severe inflammatory changes in the gastrointestinal tract);
if there are severe impairments in liver or kidney function;
in children.

Warnings and precautions
Before starting treatment with Tardyferon-Fol, discuss this with your doctor or pharmacist.
Iron-containing preparations should be used only after consultation with a doctor, especially in cases of inflammatory conditions of the stomach and intestines, delayed gastric emptying, or other confirmed gastrointestinal disorders.
Hypochromic anemia associated with inflammatory states does not respond to iron therapy. Iron treatment should, whenever possible, be combined with causal therapy.
Tardyferon-Fol must be stored out of reach of children, as even the smallest package (30 coated tablets) contains a total dose of iron which, if taken at once, may (especially in young children) lead to life-threatening poisoning.
Administration of folic acid during treatment with antiepileptic drugs may reduce blood concentrations of these drugs due to restoration of their normal metabolic rate, previously reduced by folic acid deficiency. Monitoring of antiepileptic drug levels is necessary, and dosage adjustment may be required.
Tell your doctor before taking Tardyferon-Fol:

if the patient has difficulty swallowing.

If the patient accidentally inhales a tablet, seek immediate medical attention, as there is a risk of bronchial ulceration or narrowing if the tablet enters the respiratory tract. This may cause persistent cough, coughing up blood, and/or a sensation of breathlessness, even if aspiration occurred several days or even months before symptoms appear. Therefore, prompt evaluation is needed to determine whether tablets have damaged the patient's airways.
Melanosis of the gastrointestinal tract (pigmentation in the gastrointestinal system) has been described in medical literature in elderly patients with chronic kidney disease, diabetes (high blood sugar levels), and/or hypertension (high blood pressure), who were treated with multiple medications for these conditions and also received iron supplementation due to concomitant anemia.
Due to the risk of oral cavity ulceration and tooth discoloration, tablets must not be sucked, chewed, or held in the mouth. They should be swallowed whole with water. If following this instruction is not possible or if swallowing difficulties occur, consult your doctor.

Tardyferon-Fol and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Combinations not recommended:
Iron (salts) (administered by injection):
Fainting, and even shock due to rapid release of iron from its complexed form and transferrin saturation with iron.
Concomitant use of certain antibiotics (tetracyclines) with Tardyferon-Fol reduces their effectiveness.
Iron absorption from Tardyferon-Fol is reduced when administered simultaneously:

with magnesium, phosphate, calcium, or gold salts;
if the patient is taking cholestyramine, Tardyferon-Fol should be administered 1 to 2 hours before or 4 to 6 hours after cholestyramine;
with antacids (containing aluminum, magnesium trisilicate, calcium – these should be taken at least 2 hours after administration of the iron-containing medicine);
with calcium and zinc (these should be taken at least 2 hours after administration of the iron-containing medicine).
Concomitant administration of chloramphenicol may delay the therapeutic effect of iron and its compounds.

During treatment with iron preparations, absorption of bisphosphonates, fluoroquinolones, methyldopa, levodopa and carbidopa, thyroxine, D-penicillamine, and zinc compounds is reduced (these should be taken at least 2 hours after administration of the iron-containing medicine).
The irritant effect of iron-containing medicines on the gastric and intestinal mucosa may be intensified by concomitant use of certain non-steroidal anti-inflammatory drugs (NSAIDs) (salicylates, phenylbutazone, oxyphenbutazone). These medicines should be taken at least 3–4 hours after taking the iron-containing medicine.

Due to the presence of folic acid in Tardyferon-Fol, concomitant use with other medicines requires special precautions.
Sulfonamides, sulfasalazine, methotrexate, antiepileptic drugs (such as phenobarbital, phenytoin, primidone, fosphenytoin), and sedatives negatively affect folic acid absorption.
Inform your doctor about all medicines recently taken, including those available without a prescription.

Tardyferon-Fol, food, drink, and alcohol
Do not drink large amounts of tea, coffee, or red wine, as this may reduce iron absorption. Concurrent intake of this medicine with whole-grain products (bran, legumes, oilseed plants), certain proteins (eggs), or foods and beverages containing calcium (cheese, milk, etc.) is not recommended. An interval of at least 2 hours should be maintained between administration of iron salts and consumption of these products.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine should only be administered if the expected therapeutic benefit outweighs any potential risk to the fetus.
The amount of iron and folic acid from Tardyferon-Fol that passes into breast milk has not been established, and it is unknown whether adverse effects may occur in infants breastfed by mothers receiving this treatment.
During pregnancy and breastfeeding, Tardyferon-Fol may be used only on a doctor's prescription (see section 1. What Tardyferon-Fol is and what it is used for).

Driving and operating machinery
It is unlikely that Tardyferon-Fol has any influence on the ability to drive or operate machinery.

3. How to take Tardyferon-Fol

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
The recommended dose is one tablet, i.e. 80 mg of iron ions and 0.35 mg of folic acid daily or on alternate days, during the last two trimesters of pregnancy (or from the 4th month of pregnancy).
Tardyferon-Fol tablets are intended for oral administration.
The tablets should be taken with a large glass of water, before or during meals, depending on gastrointestinal tolerance (however, food products listed in section “Tardyferon-Fol with food, drink and alcohol” should be avoided).
The tablet should be swallowed whole with water. Do not suck, chew or hold the tablet in the mouth.

Taking more Tardyferon-Fol than recommended
Cases of iron salt overdose have been reported, particularly in children, following ingestion of large amounts of the medicine.
Symptoms of overdose include signs of gastrointestinal irritation with accompanying abdominal pain, nausea, vomiting, diarrhoea, cardiovascular shock symptoms, or metabolic acidosis (rapid or shallow breathing, rapid heartbeat, headache, confusion, drowsiness, fatigue, loss of appetite), as well as liver and kidney failure.
If too much medicine has been taken, seek immediate medical attention at an emergency department for appropriate treatment.

Missing a dose of Tardyferon-Fol
If a dose is missed at the usual time, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose and take the next tablet at the regular scheduled time.
Do not take a double dose to make up for a missed dose.

Stopping Tardyferon-Fol
Tardyferon-Fol should be taken for as long as your doctor recommends. Premature discontinuation of treatment may result in recurrence of the condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The reactions are listed below in decreasing order of frequency.
Common (may affect more than 1 in 10 people)
Constipation
Diarrhea
Feeling of stomach fullness
Stomach pain
Discoloured stools
Nausea
Uncommon (may affect up to 1 in 100 people)
Throat swelling (laryngeal oedema)
Unusual stools
Discomfort and pain in the upper abdomen (dyspepsia)
Vomiting
Acute gastritis (irritation of the stomach)
Itching (pruritus)
Red skin rash (erythematous rash)
Frequency not known (cannot be estimated from the available data)
Hypersensitivity reactions including anaphylactic reactions (severe, potentially life-threatening allergic reactions)
Angioedema (sudden swelling of lips, cheeks, eyelids, tongue, soft palate, throat or larynx)
Urticaria and allergic dermatitis (skin allergic reactions)
Pulmonary necrosis (tissue death)*
Pulmonary granulomatosis (inflammatory condition)*
Bronchial stenosis (narrowing of the airways)*
Oesophageal ulceration*
Tooth discoloration**
Oral ulceration**
Oesophageal changes*
Gastrointestinal melanosis (pigmentation in the gastrointestinal tract)***
*Patients, especially elderly patients and those with swallowing difficulties, may also be at risk of pharyngeal or oesophageal ulceration (the tube connecting the mouth to the stomach). If the tablet enters the respiratory tract, there is a risk of bronchial ulceration, which may lead to bronchial stenosis.
**In case of improper administration, when tablets are chewed, sucked, or held in the mouth.
*** Gastrointestinal melanosis (pigmentation in the gastrointestinal tract) has been reported in medical literature in elderly patients with chronic kidney disease, diabetes (high blood sugar levels) and/or hypertension (high blood pressure), who were treated with multiple medications for these conditions and received iron supplementation due to concomitant anaemia.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tardyferon-Fol

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tardyferon-Fol contains

The active substances are: iron(II) in the form of iron(II) sulfate, dried, in a dose of 80 mg, and folic acid in a dose of 0.35 mg.
Other components are: tablet core: ammonium methacrylate copolymer (type B) dispersion (Eudragit RS 30D), ammonium methacrylate copolymer (type A) dispersion (Eudragit RL 30D), maltodextrin, triethyl citrate, talc, glycerol dibehenate, microcrystalline cellulose; coating: titanium dioxide, yellow iron oxide (E 172), red iron oxide (E 172), Sepifilm LP010 (hypromellose, microcrystalline cellulose, stearic acid), triethyl citrate.

What Tardyferon-Fol looks like and contents of the pack
30 or 100 tablets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Greece, the country of export:
Pierre Fabre Farmaka A.E.
Leof. Mesogeion 350
153 41, Ag. Paraskevi – Attica
Greece
Manufacturer:
Pierre Fabre Medicament Production
Site Progipharm
Rue du Lycée
45500 Gien
France
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Marketing Authorisation Number in Greece, the country of export: 41914/08/16-1-2009
Parallel Import Authorisation Number: 289/24